From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 06:17:14 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: April 14, 2008 |
The following new items were added to the CDRH web pages on April 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Consumer Information on: CONTAK RENEWAL® 3 AVT® Models M150, M155, M157 and M159 - P010012S037 |  |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 07:46:28 -0500 (CDT)
Subject: CDER New 4/11/2008
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April 11, 2008
- The Adverse Event Reporting System (AERS) Latest Quarterly Data Files (updated)
- Creating New Knowledge: FDA & Industry in Dialogue, May 6, 2008, Philadelphia, PA. The seventh conference between the FDA and industry sponsored by Temple University School of Pharmacy. Keynote Speaker: Janet Woodcock, M.D., Director, CDER. This conference provides participants, industry, and the FDA a forum for dialogue about critical issues affecting drug development. Agenda and registration
- New and Generic Drug Approvals
- Children’s Cetirizine Hydrochloride Sryup, Perrigo, Approval
- Fiorinal with Codeine (butalbital, aspirin, caffeine, codeine phosphate) Capsules, Watson Labs, Labeling Revision
- Lamivudine Tablets, Ranbaxy, Tentative Approval
- Levalbuterol Hydrochloride Inhalation Solution, Breath Ltd., Approval
- Oxcarbazepine Tablets, Apotex, Approval
- Theophylline and Dextrose in Plastic Container, B Braun Medical, Labeling Revision
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 11:07:46 -0500 (CDT)
Subject: Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)
Private Selection Ice Cream Recalled From Kroger Stores In Twelve Southeastern States (April 7)
Mon, 14 Apr 2008 10:50:00 -0500
Inter-American Products, Inc., a division of The Kroger Co., today announced a recall on two codes of Private Selection Light Churned Mint Chocolate Chip Ice Cream in 1.75-quart containers with a "Sell By" date of December 3, 2008. The two codes are: DEC0308 8070 and DEC0308 8080.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 16:05:50 -0500 (CDT)
Subject: Salmonella Illnesses May be Linked to Recalled Cereal
Salmonella Illnesses May be Linked to Recalled Cereal
Mon, 14 Apr 2008 14:10:00 -0500
At least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 16:09:34 -0500 (CDT)
Subject: FDA News Digest
FDA News Digest
April 14, 2008
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IN THIS WEEK'S ISSUE
» News
-- More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized
» Consumer Health Information More Than $100,000 of Unapproved Drugs Marketed as 'Natural Supplements' Seized At FDA's request, http://www.fda.gov/bbs/topics/NEWS/2008/NEW01817.html
SAFETY ALERTS/RECALLS
Safety Alert:
› FDA has announced that at least 23 people in 14 states have been diagnosed with salmonellosis caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal. The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private-label brands including
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01819.html
Food Recall:
› Cracker Barrel Chocolate-Covered Almonds and Chocolate Double-Dipped Peanuts; 5-oz. bags
Reason for recall: packaging is mislabeled
http://www.fda.gov/oc/po/firmrecalls/crackerbarrel04_08.html
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Apr 2008 13:03:28 -0500 (CDT)
Subject: FDA MedWatch- Herbal Science International, Inc. Recalls Dietary Herbal Supplements Because They May Present A Serious Health Hazard To Consumers
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Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue and a list of the recalled products at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herbal
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